Jeske Smink

Aicuris develops novel anti-viral therapies for patients with weakened immune systems. The pipeline includes the late-stage candidate pritelivir, a small molecule, which targets refractory and resistant HSV infections in vulnerable patient populations. An antisense oligonucleotide candidate designed specifically to treat reactivation of the BK virus (BKV) in kidney transplant recipients, is currently in early-stage clinical development. At AiCuris, I lead CMC development of the different therapeutic modalities throughout the different clinical phases. I’m responsible for the strategic and operational oversight of the different activities including manufacturing, but also CMC regulatory activities. Key responsibilities include - Overseeing CMC development for an oligonucleotide program (Clinical Phase 2) and small-molecule programs (Clinical Phase 3 and NDA/MAA), including scale-up activities, GMP manufacturing, and CMO management - Leading a cross-functional CMC team and responsibility for budgeting and project planning across the different modalities and clinical phases - Contribute to and review regulatory CMC dossiers, including Quality sections of IND/IMPD/NDA filings and briefing documents - Serving as the company’s CMC representative, specifically for the oligonucleotide program, in managing interactions with CMOs and strategic partners

Silence Therapeutics develops drugs that leverage RNA interference (RNAi) to target and disable disease-associated genes. Using the proprietary mRNAi GOLD™ platform, Silence focuses on siRNA drugs in hematology, cardiovascular disease, and rare diseases. At Silence Therapeutics, I led CMC development, being responsible for the strategic and operational oversight of process and analytical development, scale-up, and GMP manufacturing of siRNA compounds. My role included managing the quality sections of regulatory submissions, ensuring thorough and compliant documentation. Key responsibilities included: - Planning, budgeting, and executing CMC development projects of oligonucleotides, including process and analytical development, scale-up, manufacturing under GMP, and CMO oversight, while managing cross-functional stakeholder collaboration. - Leading the Drug Substance and CMC Analytical teams, supervising multiple CMC project managers, the Starting Material Lead, and analytical chemists to ensure seamless project execution and team performance. - Overseeing supply chain management efforts, developing and implementing new strategies for proprietary starting materials to optimize production and resource utilization. - Coordinating CMC activities across the supply chain, from raw materials to final drug products, and ensuring data generation for regulatory submissions. - Authoring and contributing to regulatory CMC dossiers, including Quality sections of INDs/IMPDs and briefing documents, and participating in Scientific Advice Meetings with regulatory authorities. - Serve as the external company representative, managing interactions with CMOs, scientific organizations, and strategic partners to drive collaboration and partnership success. - Maintaining and expanding expertise in siRNA drug development, manufacturing, and characterization, while continuously monitoring and integrating new advancements in the field.

ProBioGen AG is a Contract Development and Manufacturing Organization (CDMO), performing cell line engineering, process development, up to GMP manufacturing of biopharmaceuticals for clients in biotech and pharma. My work at ProBioGen AG focused on CMC project management, being responsible for projects including USP and DSP process development, analytical development and large scale production of pre-clinical and clinical material. This included: - Leading CMC project management for drug substance development of biopharmaceuticals, including novel biologics and biosimilars. - Spearheading planning and execution of CMC development and production projects for international biotech and pharma clients across the USA, EU, and Asia. - Defining key project components for process development of both USP and DSP, analytical methodologies, and GMP-compliant drug substance manufacturing. - Accountable for the technical integrity, timely delivery, and commercial success of all assigned projects. - Responsible for innovation management within the production department

The co.don® AG is a biotechnology company that develops and manufactures personalized cell therapies, focusing on the regeneration of cartilage. My work at the co.don® AG focused on the scientific management of R&D projects in the field of Advanced Therapy Medicinal Products (ATMPs) and cartilage tissue engineering, mainly in frame of a European Medicines Agency (EMA) central marketing authorization process (MAA). This included: - Project management for preclinical and quality initiatives in support of the MAA for a cell therapy targeting cartilage regeneration. - Served as the quality expert for the MAA of the spherox® product. - Supervised and mentored scientific and technical staff, including B.Sc., M.Sc., and PhD students. - Authored a range of scientific documents, including preclinical reports, MAA submission documents, and peer-reviewed publications. - Established and fostered collaborations with key scientific and medical leaders in the fields of cell therapy and regenerative medicine. - Drove innovation management, advancing current cell-based therapies while spearheading the development of novel therapeutic solutions.

See description Head Scientific Affairs

"Molecular Mechanisms in Bone Biology" My work at BCRT and MDC focussed on the regulation of bone homeostasis and disturbance of this homeostasis in bone diseases, including osteoporosis and cancer-induced bone lesions. The aim was to reveal novel components of the transcription factor network (and down-stream targets) that regulate bone cell differentiation, including both osteoblasts and osteoclasts and how this is distorted in bone diseases. I have used both animal as well as in vitro model systems. Knowledge obtained from these studies were confirmed in human cancer bone pathologies, such as in Giant Cell Tumor of Bone. Moreover, I was involved in writing scientific papers and reviews as well as writing grant applications and supervise PhD students. I presented this work at several international scientific meetings, which was merited several times with awards.

"Molecular Mechanisms in Bone Biology" (see description Project leader BCRT)

Function of the transcription factor CCAAT/Enhancer Binding Protein beta in bone development and bone tumourigenesis

Function of the transcription factor CCAAT/Enhancer Binding Protein beta in bone development and bone tumourigenesis

During my PhD thesis I have worked on the effects of glucocorticoids on the growth plate and on the insulin-like growth factor (IGF) system using both animal and in vitro models. This research was performed to gain insight in longitudinal growth problems in children receiving glucocorticoid therapy, with a focus on changed growth factor levels.